BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3398318 · Received October 9, 2013

    Report

    Report Number
    2649622-2013-11270
    Event Type
    Injury
    Date Received
    October 9, 2013
    Report Date
    July 4, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET, AND THERE WAS OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). FOURLEAD FAILURE PREDICTOR EPISODES OF LESS THAN 220 MS V-V CYCLE ARE RECORDED ON (B)(6) 2013. 64 LIFETIME V-SIC OCCUR SINCE (B)(6) 2013. LEAD INTEGRITY ALERT (LIA) TRIGGERED ON (B)(6) 2013 DUE TO MEETING THE CONDITIONS FOR NON-SUSTAINED TACHYCARDIA AND VENTRICULAR SIC. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD EXHIBITED OVERSENSING AND/OR NOISE SIGNALS AND FRACTURE OR INSULATION DAMAGE WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED AND A CUT IN THE LEAD OUTER INSULATION WAS CONFIRMED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511577 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R